Phase 4 N=515 Randomized Quadruple-blind Supportive Care

PO vs. IV Acetaminophen Given Perioperatively for 24 hr Post-op Pain Control Following Total Hip or Knee Replacement

Post-op Pain

Bottom Line

View on ClinicalTrials.gov: NCT02244619 ↗

Enrolled (actual)

515

Serious AEs

0.0%

Results posted

Jul 2017

Primary outcome: Primary: Total Post-operative Use of Opioids — 21.7; 21.7 Morphine milligram equivalents (MME)

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Oral acetaminophen (Drug); IV acetaminophen (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Kettering Health Network
Primary completion: Apr 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Total Post-operative Use of Opioids	21.7; 21.7	—
SECONDARY Patient-rated Pain in the Post-operative Period	3.6; 3.4	—

Summary

The purpose of the study is to evaluate post-op pain requirements in patients undergoing hip or knee replacement surgery who perioperatively receive either Oral acetaminophen or IV acetaminophen

Eligibility Criteria

Inclusion Criteria

18 years of age and older
Able to provide written consent
Able to read and write in English
Weighing over 50 kg
Will undergo total hip or total knee joint replacement

Exclusion Criteria

Non-verbal patients
Unable to use numeric pain scale
Allergic to the test article
Documented hepatic impairment or failure
Current illicit drug use
Requires traumatic or emergent surgery
Pregnant women
Women who are breastfeeding
Prisoners
Cognitively impaired requiring Legally Authorized Representative (LAR) or Power of Attorney (POA)
Unable to swallow oral capsules

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02244619). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.